| Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
| 510(k) Number |
K931073 |
| Device Name |
CATH-FINDER |
| Applicant |
| PHARMACIA DELTEC, INC. |
| 1265 GREY FOX RD. |
|
ST. PAUL,
MN
55112
|
|
| Applicant Contact |
DAVID H SHORT |
| Correspondent |
| PHARMACIA DELTEC, INC. |
| 1265 GREY FOX RD. |
|
ST. PAUL,
MN
55112
|
|
| Correspondent Contact |
DAVID H SHORT |
| Regulation Number | 880.5200 |
| Classification Product Code |
|
| Date Received | 03/02/1993 |
| Decision Date | 05/05/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|